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Pharmacometrics Group Leader I&I (Senior Director)

Employer
Pfizer
Location
Groton, Connecticut
Salary
Competitive
Closing date
Mar 14, 2021

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Sector
Pharmaceutical, Physicians/Nurses
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
ROLE SUMMARY
  • Provides line leadership and management to Pharmacometricians and Pharmacometricians-NCA.
  • Responsible for resourcing, recruitment, supervision, training and staff development in pharmacometrics.
  • Accountable and responsible for the implementation of pharmacometric components of MIDD strategies and pharmacometrics deliverables for the assigned projects within sphere of influence either directly or via Pharmacometricians/ Pharmacometrician-NCA.
  • Responsible for implementation of pharmacometric processes, tools, training to Pharmacometrics and Clinical Pharmacology organization, as applicable


ROLE RESPONSIBILITIES
  • Responsible for resourcing, recruitment, supervising, training, motivating and developing colleagues in Pharmacometrics.
  • Coaches and mentors Pharmacometricians and Pharmacometricians-NCA.
  • Responsible for ensuring appropriate pharmacometrics representation on projects and provision of pharmacometric expertise and leadership and allocating appropriate resources.
  • Responsible for ensuring application of state-of-the-art pharmacometric analyses and strategy to design, deliver, and report the assigned pharmacometric analyses and ensuring overall scientific accountability.
  • Provides leadership to identify opportunities for pharmacometric applications to improve drug development and decision-making.
  • Provides pharmacometric expertise and leadership to develop/improve best practices, efficient and standardized processes, and tools supporting pharmacometric deliverables.
  • Ensures compliance with internal and external guidelines.
  • Stays abreast of literature, regulatory guidelines, and relevant internal guidance for specific pharmacometric projects.
  • Manages and initiates external collaborations with pharmacometric experts to develop new methodologies.
  • Influences the external environment through publications and presentations and through participation and leadership of scientific organizations, consortia, and other collaborations to shape the future direction of pharmacometrics.
  • Manages relationships and collaboration for internal partner organizations (Busines Technology, Information Management, Statistical Programming & Analysis, Global Biometrics, Data Management, Procurement, Finance, etc) as needed for coordination on delivery of primary remits for Clinical Pharmacology and Pharmacometrics.
  • May represent Pharmacometrics and Clinical Pharmacology on internal governance/guidance/ scientific forums or meetings.


QUALIFICATIONS / SKILLS
  • Educational: Ph.D., Pharm. D., M.S. degree or equivalent training or experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, statistics or related discipline.
  • 10+ years of experience required with Ph.D/Pharm.D and 13+ years of experience required with M.S. degree/equivalent
  • Demonstrated experience with pharmacometrics aspects of drug development and support of regulatory submissions.
  • Demonstrated ability to manage cross-functional teams and develop effective partnership.
  • Pharmacometrics: demonstrates thorough understanding of, and application of quantitative modeling and simulation principles associated with MIDD.
  • Communication Skills: demonstrates ability to effectively present pharmacometric data, development plans and strategies to various audiences in both verbal and written form; demonstrates ability to write pharmacometric results, interpretations (including impact) and conclusions for reports and regulatory documents that are clear and concise.
  • Scientific Excellence: demonstrates understanding of the complexities and recent developments in pharmacometric and the implications for drug development.
  • Regulatory Knowledge: understands and is able to apply appropriate FDA and other regulatory guidelines in pharmacometrics.
  • Networking and Alliance Building: good interpersonal skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise; ability to garner support and coordinate resources in support of development objectives.
  • Big Picture/Strategic Thinking: ability to demonstrate a broad perspective on the overall compound development and how pharmacometric contributes; ability to understand all stakeholder needs.
  • Innovation: constantly looking for new approaches and able to devise/apply new techniques in pharmacometrics.
  • Courage with Decisiveness to Act: bias towards action to achieve goals; excitement, enthusiasm and a sense of urgency with regard to the development of drug candidates.


ORGANIZATIONAL RELATIONSHIPS
  • Reports to Global Head of Pharmacometrics.
  • Matrixed relationships particularly with Global Clinical Pharmacology, Clinical Leads, Clinicians, Statisticians, Clinical Research Operations, and Pharmacokinetics, Dynamics and Metabolism (PDM), and other groups as required.


RESOURCES MANAGED
  • Manages Pharmacometricians /Pharmacometricians-NCA as reports.
  • May manage one or more administrative professionals as reports.
  • May manage outsourced resources and contracted/academic affiliates.


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Other Job Details:
  • Eligible for Employee Referral Bonus
  • Eligible for Relocation Package


Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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